NCT04126668

A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers

A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.

Detailed description

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	CM082 with fed or fasting	The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.

Timeline

• Start date: 2019-12-19
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2019-10-15
• Last updated: 2020-05-21

Locations

1 site across 1 country: China